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21 CFR Part 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE. eCFR · Authorities (U.S. Code) · prev | next · Subpart A - General Provisions (§§ 341.1 - 341.3) · Subpart B - Active Ingredients (§§ 341.12 - 341.40) · Subpart C
341.76 - Labeling of bronchodilator drug products. § 341.78 - Labeling of expectorant drug products. § 341.80 - Labeling of nasal decongestant drug products. § 341.85 - Labeling of permitted combinations of active ingredients. § 341.90 - Professional labeling. Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
The statements of identity, indications, warnings, and directions for use, respectively, applicable to each ingredient in the product may be combined to eliminate duplicative words or phrases so that the resulting information is clear and understandable. (a) Statement of identity. For a combination drug product that has an
The following combinations are permitted provided each active ingredient is present within the dosage limits established in parts 341, 343, and 356 of this chapter and the product is labeled in If age is used to determine the dose, the directions must include instructions to reduce the dose for low-weight children.
PART 341 -- COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE. Subpart B--Active Ingredients
15 Jun 2017 18 CFR Part 341 - OIL PIPELINE TARIFFS: OIL PIPELINE COMPANIES SUBJECT TO SECTION 6 OF THE INTERSTATE COMMERCE ACT. eCFR · Authorities (U.S. Code) · Rulemaking · prev | next · § 341.0 Definitions; application. § 341.1 Electronic filing of tariffs and related materials. § 341.2 Filing
For the purpose of this part, including all forms and instructions promulgated for use in connection herewith, unless the context otherwise requires: (a) The term transfer agent means any person who engages on behalf of an issuer of qualifying securities or on behalf of itself as an issuer of qualifying securities in: (1)

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March 2018